BEUDAMED
    7 results · 68ms · Sources: EU EUDAMED, US FDA

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    FLUORESCEIN CONJUGATED ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Immunology

    HeartSpan Steerable Sheath Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SELECTATEC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    O-ARM 1000 IMAGING SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·April 24, 2014

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 30, 2007

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 1, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022